Barron Radial Vacuum Trephine Set Recalled Due to Compromised Sterile Seal
Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine Sets because the sterile seal may be compromised, allowing product to fall out of the pouch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a compromised sterile barrier, which is a potential risk but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I). It is not a cosmetic defect, so it is not Low.
Plain-English summary
Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. (Ref. K20-2062, Lot 122336). The recall involves one unit of the ophthalmic instrument set.
The recall was initiated because the seal that maintains a sterile barrier for the reprocessed medical device became compromised. This defect may allow the product to fall out of the pouch, potentially compromising sterility.
The product was distributed nationwide. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 122336
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
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